Local biomechanical and/or antimicrobial ligation device
A ligation device is disclosed that is capable of containing a fluid, e.g., a biomechanical medium or an antimicrobial solution. The ligation device comprises an upper clip and a lower clip, each having a locking feature that enables the upper clip and the lower clip to be movably attached to each other.
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1. Technical Field
The present disclosure relates to apparatus and methods for joining tissue portions and occluding vessels.
2. Background of Related Art
Ligation devices are used to join tissue portions and to occlude vessels. When tissue is held together by ligation devices that penetrate the body, the risk of foreign matter entering the site of a surgical wound is increased. To reduce the risk of infection, ligation devices can be coated with an antimicrobial or antibiotic material.
Once inserted into the body, ligation devices will remain in place unless they are either physically removed or dissolved in the body. The physical removal of non-resorbable ligation devices is a complicated surgical procedure typically involving the use of specially designed instruments.
SUMMARYThe present disclosure describes various methods and devices for tissue ligation and/or vessel occlusion. A device for delivering a localized antimicrobial solution or a biomechanical medium is described.
A ligation device may include a fastener member having a backspan and at least two prongs generally perpendicular to the backspan, a retainer portion having a connector and at least two columnar members attached to the connector, each columnar member having an aperture to receive and to retain the prongs, and a reservoir located within at least one of the columnar members. In another embodiment, the ligation device may include a fastener member having a backspan and legs generally perpendicular to the backspan with at least one leg housing a reservoir, and a retainer portion with a connector and at least two columnar members attached to the connector, each columnar member having an aperture to receive and retain the legs. The ligation device may also include a locking surface extending from at least one prong that is removably attached to a locking surface extending from at least one aperture.
Within the reservoir, a fluid such as an antimicrobial medium or solution may be stored. To facilitate storage of the fluid, a membrane seal may be positioned at the opening of the reservoir. Dispersion of the fluid may be facilitated by puncturing the membrane seal upon insertion of the fastener member into the retainer portion. The prongs of the fastener member may include a sharp distal tip to facilitate the opening of the membrane seal. A groove may be located on an inner surface of the retainer portion to facilitate dispersion of the fluid.
The various aspects of the present disclosure will be more readily understood from the following description when read in conjunction with the appended figures.
By way of description only, embodiments of the disclosure will be described with reference to the accompanying drawings, in which:
Particular embodiments of the present disclosure will be described herein with reference to the accompanying drawings. As shown in the drawings and as described throughout the following descriptions, and is traditional when referring to relative positioning on an object, the term “proximal” refers to the end of the apparatus that is closer to the user and the term “distal” refers to the end of the apparatus that is further from the user. In the following description, well-known functions or constructions are not described in detail to avoid obscuring the present disclosure in unnecessary detail.
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Fluid 15 may be for example, but is not limited to being, an antiseptic or an antimicrobial solution, a biomechanical medium, and/or a wound treatment material. Examples of antimicrobial agents include but are not limited to β-Lactam agents, such as penicillins, and cephalosporins. By way of example only, the fluid 15 may include an antimicrobial hydrogel and may be in the form of a thixotropic, non-cytotoxic hydrogel. Preferably, the fluid 15 will facilitate healing by decreasing the likelihood of infection while not inhibiting healing of the surgical site.
The ligation devices disclosed herein may be made from natural or synthetic bioabsorbable materials, including but not limited to, alloys and polymers. Examples of families of bioabsorbable polymers include polymers having glycolic and ester linkages, including but not limited to polyesters, poly (amino acids), polyanhydrides, polyortho-esters, polyurethanes, polycarbonates, poly(dioxanone) (PDO), polyethylene glycol (hydrogels, polylactides (PLA), polyglycolides (PGA), polycaprolactone (PCL), and their copolymers. Some of the polymers, such as hydrogels, are hydrophilic. Others, such as PCL, are hydrophobic. The bioabsorbable polymers may be prepared by copolymerization of various monomers to modify and improve their properties as applications demand, e.g., poly (lactide-co-glycolide) copolymers. Because these polymers degrade by hydrolysis, the type of polymer and its physical form used in a particular application has an effect in defining the degradation period. Mechanical blending, as opposed to copolymerization, can also further enhance their properties.
Biocompatible, solid-solution strengthened alloys such as iron-based alloys, cobalt-based alloys and titanium-based alloys as well as refractory metals and refractory-based alloys may be utilized in the manufacture of such implantable medical devices. For example, traditional stainless steel alloys such as 316L, i.e., UNS S31603, may be utilized as an implantable, biocompatible device material. Depending upon the material selected, degradation of the material may be accelerated after exposing the material to radiation, including but not limited to gamma radiation.
Additionally, the ligation device 100 may also be made from materials impregnated or coated with substances known to have antimicrobial properties, such as silver or an antimicrobial medium. For example, oligodynamic metals including silver, copper, iron, zinc, bismuth, gold, aluminum, and other metals are known to have antimicrobial properties.
It will be understood by those skilled in the art that various modifications and changes in form and detail may be made therein without departing from the scope and spirit of the present disclosure. Accordingly, modifications such as those suggested above, but not limited thereto, are to be considered within the scope of the disclosure.
Claims
1. A ligation device comprising:
- a fastener member having a backspan and at least two prongs generally perpendicular to the backspan;
- a retainer portion having a connector and at least two columnar members attached to the connector, each columnar member having an aperture to receive and to retain the prongs; and
- a reservoir defining a container configured to store a fluid therein, the reservoir located within at least one of the columnar members, the fastener member releasably secured to the retainer portion, wherein the fastener member is releasable from the retainer portion upon flexing of the at least two prongs toward each other, wherein the retainer portion is flexible such that the at least two columnar members are movable toward and away from each other.
2. The ligation device of claim 1 further comprising: a locking surface extending from at least one prong that is removably attached to a locking surface extending from at least one aperture.
3. The ligation device of claim 2, wherein each prong defines a distal end that is disposed within the respective columnar member when the fastener member is releasably secured to the retainer portion.
4. The ligation device of claim 1 further comprising a membrane seal at an opening of the aperture.
5. The ligation device of claim 1, wherein the prongs have a sharp distal tip.
6. The ligation device of claim 1, wherein the fluid is either an antimicrobial solution or a biomechanical medium.
7. The ligation device of claim 1, further comprising a groove located on the inner surface of the retainer portion.
8. The ligation device of claim 1, wherein at least one of the at least two prongs includes a groove and the retainer portion includes a protrusion configured to releasably engage the groove.
9. The ligation device of claim 8, wherein the fastener member is separable from the retainer member when the groove is separated from the protrusion of the retainer portion.
10. The ligation device of claim 1, wherein the retainer portion defines a gap between the at least two columnar members.
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Type: Grant
Filed: Aug 18, 2009
Date of Patent: Feb 4, 2014
Patent Publication Number: 20110046647
Assignee: Covidien LP (Mansfield, MA)
Inventors: Andrew Heeps (Kensington, CT), Jon Wojculewicz (Bristol, CT)
Primary Examiner: Corrine M McDermott
Assistant Examiner: Mark Mashack
Application Number: 12/542,883
International Classification: A61B 17/122 (20060101); A61B 17/064 (20060101); A61B 17/08 (20060101); A61M 5/00 (20060101);